The Extended Gestational Age Medical Abortion Study

Phase 4

Completed

• Conditions: Medical Abortion
• Interventions: Drug: Mifepristone and misoprostol

• Registration Number: NCT00997347
• Lead Sponsor: Gynuity Health Projects

Brief Summary

This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual misoprostol for termination of pregnancy in existing outpatient early medical abortion services among women 57-63 days' versus 64-70 days' gestation.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-10-01
• Study First Submitted QC: 2009-10-16
• Study First Posted: 2009-10-19
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-28
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1400

Inclusion Criteria

• intrauterine pregnancy of greater than 56 days and less than 71 days
• eligible for medical abortion according to study doctor assessment
• willing and able to sign consent forms
• speak English or Spanish (in US sites); speak the local language(s) (in international sites)
• agree to comply with the study procedures and visit schedule

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
64-70 days' gestational age	Mifepristone and misoprostol	Women whose pregnancies are estimated to have a gestational age of 64-70 days

Primary Outcome Measures

Name	Time	Method
Efficacy: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion	7-36 days

Secondary Outcome Measures

Name	Time	Method
Proportion of individual side effects experienced by participants	7-14 days
Proportion of women who determined method acceptable (i.e., overall acceptability of method, time to abortion completion, bleeding, side effects, and pain)	7-14 days
Bleeding patterns, i.e. proportion of women who experienced heavy, moderate, or light bleeding according by day since abortion began	7-14 days
Average number of missed days of work or school due to the abortion procedure	7-14 days

Trial Locations

Locations (12)

Zhordania Institute of Human Reproduction; 🇬🇪 Tblisi, Georgia

La Rabta Maternity Hospital; 🇹🇳 Tunis, Tunisia

Government Medical College (GMC); 🇮🇳 Nagpur, India

Presidential Women's Center; 🇺🇸 West Palm Beach, Florida, United States

Planned Parenthood League of Massachusetts; 🇺🇸 Boston, Massachusetts, United States

Naval Nursing Home; 🇮🇳 Solapur, India

Family Planning Associates Medical Group; 🇺🇸 Chicago, Illinois, United States

Planned Parenthood, Minnesota, North Dakota, South Dakota; 🇺🇸 St. Paul, Minnesota, United States

Planned Parenthood of New York City; 🇺🇸 New York, New York, United States

Planned Parenthood, Central Texas; 🇺🇸 Waco, Texas, United States

Central District Maternity House; 🇺🇦 Odessa, Ukraine

Maternity Hospital No.2; 🇺🇦 Simferopol, Ukraine